‘First Do No Harm’, the long-awaited report of the Independent Medicines and Medical Devices Safety Review has been published. The Review, chaired by Baroness Cumberledge, considered safety issue arising from the use of Primodos (a home pregnancy testing kit used between the 1950s and late 1970s), the epilepsy drug Sodium Valproate (still in use) and vaginal mesh surgery for pelvic organ prolapse and urinary incontinence (paused since July 2018 subject to a ‘high vigilance restriction’). Each has led to significant adverse outcomes for women and / or their unborn children. Baroness Cumberledge describes the failings in all three areas as systemic, spanning the breadth of the healthcare system and as ‘institutional resistance to patient safety’.

Nine specific recommendations are made around apologies, redress, specialist care, data collection and the role of the MHRA and include a new Patient Safety Commissioner – the ‘golden thread’ whose role will include advocating for patients, holding the system to account, monitoring trends and ‘above all demanding action’.

Key themes requiring action for improvement include:

  • Lack of informed consent including the need for a period of reflection and tools to facilitate.
  • Better governance arrangements around conflicts of interest (individuals and organisations).
  • Clearer signposting of how to complain. Patterns and trends should be identified and shared.
  • Failure to follow guidance which adversely impacts on patient safety should be reported by colleagues and the GMC alerted.
  • Systems for clinical audit and quality assurance should be strengthened.
  •  A culture of denial, fear of blame and absence of accountability still exists.

Whilst culture in the health sector has changed in recent years, it appears that there is still some way to go.  Healthcare organisations need to ensure that they are complying with the duty of candour and that their governance processes are robust. Patients need to be placed front and centre in the healthcare system, not just in relation to diagnosis care and treatment but particularly regarding their concerns. Consent must be fully informed allowing time for reflection and be fully documented – material risks as well as benefits. The use of mesh remains paused, so it is likely that only a very small number of these procedures will go ahead.  For those that do, extra care should be taken with consent and documentation.

The government has issued an apology but its response to the report is awaited.

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